An excellent opportunity has arisen for a Regulatory Affairs Officer to join a pharmaceutical company based in South West London on a permanent basis.
Within this role you will ensure the appropriate licensing of all post approval activities for assigned products and manage development projects for new submissions and complex variations in order to control their quality, safety and efficacy, in line with the business objectives, relevant regulatory requirements and internal and external standards.
* Responsible for the provision of full regulatory support for assigned products across the full life cycle, from prelaunch, launch, maintenance, discontinuation and divestment. Includes the preparation and submission of licence variations, implementation of SPC and pack updates.
* Manage increasingly complex submissions making decisions independently and with minimal referral to the Regulatory Affairs Manager.
* Interact directly with regulatory authorities on defined matters, liaise with, and make presentations to regulatory authorities on defined matters including negotiating regarding marketing authorisations.
* Ensure the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities.
* Provide regulatory input on artworks and ensure approval in time for product launch and compliance with legislation and guidelines.
* Maintain an up to date and developing knowledge of regulatory affairs legislation and Codes of Practice, with responsibility for completion of assigned training and own development.
* Coach more junior members of the team.
* Degree in a suitable scientific discipline (biological/chemistry/life sciences)
* Minimum of 4 to 5 years of Regulatory affairs experience in Lifecycle management preferred with exposure and knowledge of new submissions to regulatory authorities to support the company's in licensing activities
* Basic knowledge of Local and European regulatory affairs/PV legislation and guidance
* Planning and organisation skills- ability to multitask
* Able to work under pressure and to strict deadlines
* A confident credible communicator with good negotiation skills
* Good written communication skills with attention to detail.
* In depth knowledge of Local and European regulatory affairs/PV legislation and guidance
* Broad experience of managing relevant regulatory submissions, with demonstrated ability to work independently and manage complex projects.
* Able to build relationships at all levels of the business
* Excellent written communication skills with attention to detail.
* Ability to handle multiple tasks/projects and manage priorities accordingly.
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email email@example.com